Sterilization packaging systems

ABSTRACT

Sterilization packaging systems with features for sealing a volume against an ingress of contaminants are provided. Such features include a frame including a plurality of vertical members and a plurality of horizontal members, each vertical member and horizontal member having an inner side and an outer side; a sterilization wrap, a first portion of the sterilization wrap positioned adjacent the inner side of each vertical member and each horizontal member to define a volume and an opening to access the volume; and a lid for sealing the volume against an ingress of contaminants. Additionally, a sterility gauge for signaling whether the volume is sealed against contaminants also may be provided. Exemplary sterilization packaging systems may include other features as well.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.15/771,531, filed on Apr. 27, 2018, which is the national stage entry ofInternational Patent Application No. PCT/US2016/058780 having a filingdate of Oct. 26, 2016, which claims priority to U.S. ProvisionalApplication Ser. No. 62/248,401, filed on Oct. 30, 2015, all of whichare incorporated herein in their entirety by reference thereto.

FIELD OF THE INVENTION

The subject matter of the present disclosure relates generally tosterilization packaging and sterilization packaging systems.

BACKGROUND

Personnel in the Central Service Room (CSR) or the Sterile ProcessingDepartment (SPD) of hospitals are commonly charged with theresponsibility of packaging surgical supplies to ensure that thesterility of the packaged contents is maintained from sterilization tothe point of reuse. Several activities are involved in the task ofsterile supply delivery to the operating room and other units.

Much of the surgical instruments and supplies used in the operating roomare reusable. These supplies typically include such things as clamps,scalpel blade handles, retractors, forceps, scissors, surgeon's towels,basins, and the like. All of these supplies must be collected after eachprocedure, decontaminated, placed in a sterilization packaging system,and sterilized before they can be used again in another procedure. Thesterilization packaging systems used must be of the size and shape toaccommodate the items to be sterilized and must be compatible with andwithstand the physical conditions of the sterilization process.

Typical means of sterilizing instruments include, among others,autoclaving with steam, exposure to ethylene oxide gas, and exposure tohydrogen peroxide plasma, as is done with the STERRAD® SterilizationSystem from Advanced Sterilization Products, Irvine, Calif. After thepackage and its contents have been sterilized, the sterilization packagetypically is stored until it is needed for a surgical procedure.

Common sterilization packaging systems include sealable pouches,sterilization wraps, and rigid containers. Although each of thesesystems has some advantage compared to other systems, each of thesetypical packaging systems also has drawbacks. As an example, using asterilization wrap to package items to be sterilized in a certainprescribed manner will permit the entry of sterilizing vapor/gas orother medium to sterilize the contents of the wrapped package whiledenying the ingress of contaminants such as bacteria and other infectioncausing materials or their vehicles after sterilization. As such,sterilization wraps generally provide a consistent barrier against theingress of contaminants. However, during storage and transfer to theoperating room, the wrapped package may be handled several differenttimes; each time the wrapped package is handled, there is a potentialthat the sterile nature of the package contents can be compromised,e.g., by a tear, cut, or other breach of the wrapping material.

As another example, sterilization containers—such as, e.g., a metal boxand a rigid top or lid that closes the metal box—also can permit theentry of sterilizing medium while denying the ingress of contaminantsafter sterilization. Unlike sterilization wraps, rigid sterilizationcontainers usually avoid tears, cuts, and the like that can compromisethe sterilized contents of the container. However, typical rigidsterilization containers are complex packaging systems, includingseveral parts that must be precisely assembled to prevent compromisingthe contents of the container after sterilization. Further, some partsof the sterilization container assembly are prone to warping, denting,and breakage, as well as mismatching, loss, and/or other damage. Thus,even if the parts of the container can be assembled, damaged parts canprevent proper assembly of the sterilization container and thereby allowthe ingress of contaminants after sterilization.

Consequently, there is a need for a sterilization packaging system thatovercomes the shortcomings of known packaging systems. In particular, asterilization packaging system that reduces the number of packagingcomponents and the number of steps required to assemble thesterilization packaging system while minimizing the costs of and thematerial required for the sterilization packaging system would bebeneficial. Additionally, a sterilization packaging system that providesa consistent barrier against the ingress of contaminants while avoidingpost-sterilization breaches of the packaging system would beadvantageous. Moreover, a sterilization packaging system that increasesconfidence that a sterilized package has not been breached also would beuseful.

SUMMARY

The present invention provides sterilization packaging systems withfeatures for sealing a volume against an ingress of contaminants. Suchfeatures include a sealing assembly, where the sealing assembly includesa sheet of sterilization material and a clamp for sealing the sheet ofsterilization material against a container to seal the volume of thecontainer from contaminants. The features further include asterilization wrap and a lid for sealing a volume defined by thesterilization wrap and a frame. The present disclosure also provides asealing assembly including a sheet of sterilization material and a clamphaving open position and clamped positions. The clamp is configured toextend about a perimeter of a container, the sheet of sterilizationmaterial is disposed between the container and the clamp when the clampis in the clamped position to seal a volume of the container, and theclamp is held in the clamped position by a latch. Additional aspects andadvantages of the invention will be set forth in part in the followingdescription, may be apparent from the description, or may be learnedthrough practice of the invention.

In one aspect, the present subject matter is directed to a sterilizationpackaging system. The sterilization packaging system includes a frame, asterilization wrap, and a lid. The frame defines a vertical directionand may include a plurality of vertical members extending along thevertical direction and a plurality of horizontal members extendingperpendicular to the vertical direction. Each vertical member andhorizontal member of the frame may have an inner side and an outer side.The sterilization wrap may include a first portion positioned adjacentthe inner side of each vertical member and each horizontal member todefine a volume and an opening to access the volume. Further, thesterilization wrap may be disposed between the lid and the frame.Moreover, the lid may be provided to seal the volume against an ingressof contaminants. In certain embodiments, the sterilization wrap isdisposable. It should be understood that the sterilization packagingsystem may be further configured with any of the additional features asdescribed herein.

In some embodiments, the frame is constructed from a rigid material. Inanother embodiment, the vertical members and the horizontal members ofthe frame may define a plurality of windows. As such, the sterilizationwrap may be visible through the windows.

In another embodiment, the sterilization wrap of the sterilizationpackaging assembly may include a second portion. The second portion maybe positioned across the opening defined by the sterilization wrap andthe frame to cover the opening. In some embodiments, the lid ispositioned in contact with the second portion of the sterilization wrapto seal the volume. In still other embodiments, the sterilization wrapmay be folded over to define the second portion of the sterilizationwrap. When the sterilization wrap is folded, a fold may be definedbetween the second portion and the first portion of the sterilizationwrap.

In another embodiment, the lid may comprise a lip defined along aperimeter of the lid. The lid also may include a flange adjacent thelip, and the flange may define a recess. A gasket may be positioned inthe recess to seal the volume from contaminants. In some embodiments,the gasket may be an inflatable gasket. Alternatively or additionally, aportion of the sterilization wrap is disposed between the gasket and aflange of the frame. In still other embodiments, a depression may bedefined along the lip defined by the perimeter of the lid. Thedepression may be configured such that a second sterilization packagingsystem may be stacked on top of the lid.

In yet another embodiment, the lid comprises a plurality of ribs. Assuch, the ribs may, for example, support a sterilization packagingsystem stacked on top of the lid or may provide rigidity to the lid.

In still other embodiments, the sterilization packaging system mayinclude a sterility gauge for signaling whether the volume is sealedagainst contaminants. More specifically, the sterility gauge maycomprise a binary visual signal.

In another embodiment, the lid is positioned adjacent a top portion ofthe frame to seal the volume against contaminants. In some embodiments,the lid may have a shape complementary to a shape defined by the topportion of the frame.

In another aspect, the present subject matter is directed to asterilization packaging system including a frame defining a verticaldirection. The frame includes a plurality of vertical members extendingalong the vertical direction and a plurality of horizontal membersextending perpendicular to the vertical direction. Each vertical memberand horizontal member has an inner side and an outer side. Thesterilization packaging system further comprises a sterilization wrap. Afirst portion of the sterilization wrap is positioned adjacent the innerside of each vertical member and each horizontal member to define avolume and an opening to access the volume. The sterilization packagingsystem also includes a lid for sealing the volume against an ingress ofcontaminants and a sterility gauge for signaling whether the volume issealed against contaminants. The sterility gauge is positioned on thelid.

It should be appreciated that the sterilization packaging system may befurther configured with any of the additional features as describedherein. For example, in some embodiments, the sterility gauge comprisesa binary visual signal. Alternatively or additionally, a second portionof the sterilization wrap may be positioned across the opening to coverthe opening. Further, the lid may be positioned in contact with thesecond portion of the sterilization wrap to seal the volume.

In yet another aspect, the present subject matter is directed to asterilization packaging system that comprises a frame defining avertical direction. The frame includes a plurality of vertical membersextending along the vertical direction and a plurality of horizontalmembers extending perpendicular to the vertical direction. Each verticalmember and horizontal member has an inner side and an outer side. Thesterilization packaging system further comprises a sterilization wrapincluding a first portion and a second portion, and the first portiondefines a volume. The sterilization packaging system also includes a lidfor sealing the volume against an ingress of contaminants. The firstportion of the sterilization wrap is positioned adjacent the inner sideof each vertical member and each horizontal member to define the volumeand an opening to access the volume. The second portion of thesterilization wrap is configured to be positioned across the opening tocover the opening, and the lid is configured to be positioned in contactwith the second portion of the sterilization wrap to seal the volume. Itshould be understood that the sterilization packaging system may befurther configured with any of the additional features as describedherein.

These and other features, aspects, and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims. The accompanying drawings, which areincorporated in and constitute a part of this specification, illustrateembodiments of the invention and, together with the description, serveto explain the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A full and enabling disclosure of the present invention, including thebest mode thereof, directed to one of ordinary skill in the art, is setforth in the specification, which makes reference to the appendedfigures, in which:

FIG. 1 provides a perspective view of a sterilization container systemas generally known in the art.

FIG. 2 provides a perspective view of a sterilization wrap system asgenerally known in the art.

FIG. 3 provides a perspective view of a sterilization packaging systemhaving a clamp in a closed or clamped position according to an exemplaryembodiment of the present subject matter.

FIG. 4 provides a perspective view of the sterilization packaging systemof FIG. 3 with the clamp in an open position according to an exemplaryembodiment of the present subject matter.

FIG. 5 provides a perspective, exploded view of the sterilizationpackaging system of FIG. 4.

FIG. 6 provides a partial cross-section view of the sterilizationpackaging system of FIG. 3.

FIG. 7 provides a perspective view of two stacked sterilizationpackaging systems according to an exemplary embodiment of the presentsubject matter.

FIG. 8 provides a perspective view of a sterilization packaging systemaccording to an exemplary embodiment of the present subject matter.

FIG. 9 provides a perspective, exploded view of the sterilizationpackaging system of FIG. 8.

FIG. 10 provides a perspective view of a portion of the sterilizationpackaging system of FIG. 8.

FIG. 11 provides a perspective, partially exploded view of thesterilization packaging system of FIG. 8.

FIG. 12 provides a partial cross-section view of the sterilizationpackaging system of FIG. 8.

FIG. 13 provides a perspective view of two stacked sterilizationpackaging systems according to an exemplary embodiment of the presentsubject matter.

DETAILED DESCRIPTION

Reference now will be made in detail to embodiments of the invention,one or more examples of which are illustrated in the drawings. Eachexample is provided by way of explanation of the invention, notlimitation of the invention. In fact, it will be apparent to thoseskilled in the art that various modifications and variations can be madein the present invention without departing from the scope or spirit ofthe invention. For instance, features illustrated or described as partof one embodiment can be used with another embodiment to yield a stillfurther embodiment. Thus, it is intended that the present inventioncovers such modifications and variations as come within the scope of theappended claims and their equivalents.

Described herein is a sterilization packaging system and componentsthereof suitable for use in a variety of procedures for containing,sterilizing, storing, and using sterilized items such as surgicalsupplies. While described in conjunction with its use in hospital andsurgical room procedures, the present subject matter is intended for usewherever there is a need for sterilized materials. Consequently, thefollowing description should not be considered a limitation as to thescope of use of the present subject matter.

FIG. 1 provides a perspective view of a sterilization container systemas described above and as generally known in the art. In typicalcontainer systems, such as container system 10, one or more items to besterilized are placed in a container 12, which generally is a rigidmetal box. Container 12 may define one or more vents 14. A lid or top 16is placed on container 12 to seal container 12 for sterilization. Asshown, lid 16 may define one or more vents 18, and a gasket 20 may bepositioned between lid 16 and container 12 to improve the seal betweencontainer 12 and lid 16. Further, typical sterilization container system10 includes several filter assemblies 22, each filter assembly 22 havinga filter 24, a retention plate 26, and multiple gaskets 28. As shown,the filter assemblies 22 usually are positioned within container system10 adjacent vents 14, 18 defined by container 12 and lid 16. As will bereadily understood, sterilization container system 10 generally is acomplex assembly, comprising a multitude of parts that can be lost,damaged, or improperly assembled. Lost parts require replacement, whichincreases the cost of container system 10, and damaged or improperlyassembled container systems 10 can lead to post-sterilizationcontamination of the items contained in container 12 by permitting theingress of contaminants into the container system 10.

FIG. 2 provides a perspective view of a sterilization wrap system 50 asdescribed above and as generally known in the art. To wrap an item forsterilization, such as one or more surgical implements or other itemsrequiring sterilization, the item is placed on top of sterilization wrap52 in contact with an inner surface of sterilization wrap 52 such thatthe four corners of sterilization wrap 52 can be folded over the itemone at a time to fully wrap the item and form a wrapped package.Sterilization wrap 52 must be of a size large enough to fully wrap theitems to be sterilized. Usually, each fold of the sterilization wrap 52folds over most of the item or items to be sterilized, and eachsubsequent fold overlaps the previous fold, leaving the item or items tobe sterilized completely encompassed within the folds of sterilizationwrap 52. Further, a sealing mechanism 54, such as one or more of anadhesive, tape, mechanical fastener, or the like, may be applied tosterilization wrap 52 to hold the folds of wrap 52 in place. Afterwrapping, an outer surface 56 of sterilization wrap 52 forms theresulting exterior surfaces of the wrapped item or package.Alternatively, the items to be sterilized may be placed in a tray thatis then wrapped with sterilization wrap 52 such that outer surface 56 ofwrap 52 is the exterior surface of the wrapped package. Becausesterilization wrap 52 forms the outer surface of sterilization wrapsystem 50, system 50 is prone to breaches such as, e.g., cuts, tears, orthe like, which can lead to post-sterilization contamination of thewrapped items by permitting the ingress of contaminants into the wrappedpackage.

Referring now to FIGS. 3 and 4, perspective views are provided of asterilization packaging system according to an exemplary embodiment ofthe present subject matter. In the depicted embodiment, sterilizationpackaging system 100 includes a container 102 for containing one or moreitems to be sterilized and a sealing assembly 104, which seals container102 from the ingress of contaminants such as, e.g., bacteria and otherinfection causing materials or their vehicles. Sealing assembly 104includes a sheet 106 of sterilization material and clamp 108. As shownin FIG. 3, clamp 108 has an open position for assembling sterilizationpackaging system 100 and for retrieving when needed the sterilized itemswithin container 102, and as shown in FIG. 4, clamp 108 has a closed orclamped position for sealing container 102 against the ingress ofcontaminants. Once sealed, the sealed sterilization package can then betransferred to sterilizing equipment and exposed to sterilizationconditions as generally known in the art. Such sterilization conditionscan include, e.g., steam, ethylene oxide, or hydrogen peroxide plasmasterilization conditions. Sterilization conditions are the conditionspresent during a particular sterilization methodology utilized thatsubstantially or completely destroys bacteria and other infectiousorganisms in an industrial or medical product.

Referring now to FIGS. 5 through 7, sterilization packaging system 100will be described in greater detail. Container 102 defines a verticaldirection V, a longitudinal direction L, and a transverse direction T,which are orthogonal to one another. Container 102 further defines avolume 110 for containing items to be sterilized. More particularly,container 102 includes one or more vertical walls 112 extending alongthe vertical direction V and one or more horizontal walls 114 extendingperpendicular to the vertical direction. The one or more vertical andhorizontal walls 112, 114 define volume 110.

In some embodiments, such as the depicted exemplary embodiment,container 102 may be generally rectangular in shape, having fourvertical walls 112 and one horizontal wall 112 defining volume 110. Insuch embodiments, container 102 may define a first side 116 ofsterilization packaging system 100 opposite a second side 118, e.g.,first side 116 is spaced apart from second side 118 along transversedirection T, and a third side 120 opposite a fourth side 122, e.g.,third side 120 is spaced apart from fourth side 122 along longitudinaldirection L. Moreover, as shown, container 102 may include one or morehandles 124, e.g., for ease in transporting sterilization packagingsystem 100. For example, one handle 124 may be attached or pivotallycoupled to a vertical wall 112 at first side 116 of system 100 andanother handle 124 may be attached or pivotally coupled to a verticalwall 112 at second side 118, i.e., handles 124 may be attached orcoupled on opposite sides of container 102. Of course, container 102also may have other shapes or configurations, e.g., container 102 may begenerally round in shape, include walls at an angle to the verticaldirection V, include any number of handles 124, or may omit handles 124.

Further, container 102 has a perimeter 126 defining an opening 128through which the items to be sterilized are placed within volume 110 ofcontainer 102. Perimeter 126 generally is defined by an uppermostportion of vertical walls 112. As shown in FIG. 5, perimeter 116 isdefined vertically opposite horizontal wall 114, i.e., in theillustrated embodiment, perimeter 126 is defined at the uppermostportion of vertical walls 112 and horizontal wall 114 is defined at thelowermost or bottommost portion of vertical walls 112. Referringparticularly to FIG. 6, container 102 may define a groove 130 nearperimeter 126. For example, groove 130 may be defined in vertical walls112 and may extend about container 102 at a constant distance fromperimeter 126.

As stated, sterilization packaging system 100 includes a sealingassembly 104 for sealing items within container 102, the sealingassembly including a sheet 106 of sterilization material and clamp 108.In exemplary embodiments of the present subject matter, sealing assembly104 is disposable, i.e., both sheet 106 and clamp 108 may be disposed ofafter they are used to seal container 102, while container 102 may bereused. In other embodiments, sheet 106 and/or clamp 108 may bereusable.

As depicted in FIGS. 5 and 6, sterilization material sheet 106 isdisposed between clamp 108 and container 102. More particularly, sheet106 is positioned to extend across opening 128 of container 102 suchthat when clamp 108 is in the closed or clamped position on container102, with the sheet 106 of sterilization material between clamp 108 andcontainer 102, opening 128 is sealed closed to prevent the ingress ofcontaminants into volume 110. Further, as illustrated in FIGS. 5 and 6,an excess 132 of material may extend from beneath clamp 108, in adirection generally away from or outward from container 102, such thatthe excess material 132 defines a perimeter 134 of sterilizationmaterial sheet 106.

Sheet 106 can be made from a number of materials and, generally, may bemade of a material from one of two main classes, reusables anddisposables. Reusables are materials that, as the name suggests, can bereused, typically by washing or some other form of cleaning.Disposables, on the other hand, usually are one-use items that arediscarded or recycled after their initial use. Generally, cloth, linen,or other woven materials fall into the reusable category whiledisposables normally include nonwoven materials made from either or bothnatural and synthetic fibers such as paper, fibrous polymeric nonwovens,and films, which are capable of passing sterilants and retardingtransmission of bacteria and other contaminants.

Nonwoven sterilization materials present several advantages due to theirbarrier properties, economics, and consistent quality. The nonwovenmaterials can be made from a variety of processes including, but notlimited to, air laying processes, wet laid processes, hydroentanglingprocesses, spunbonding, meltblowing, staple fiber carding and bonding,and solution spinning. The fibers themselves can be made from a varietyof both natural and synthetic materials including, but not limited to,cellulose, rayon, nylon, polyesters, polyolefins, and many othermaterials. The fibers may be relatively short, staple length fibers,typically less than three inches, or longer and substantially morecontinuous fibers such as are produced by spunbonding and meltblowingprocesses. Whatever materials are chosen, the resultant sterilizationmaterial 106 must be compatible with the particular sterilizationtechnique being used and must also provide both strength and barrierproperties to maintain the sterile nature of the contents of thesterilization package system 100 until use. In the illustrated exemplaryembodiment, sheet 106 of sterilization material is a transparentbreathable film, but in other embodiments, sheet 106 may be atranslucent or opaque material, such as, e.g., a translucent breathablefilm, a SMS material (described below), or the like. For example, sheet106 may be a sterilization wrap such as described in more detail below.

Referring still to FIGS. 5 and 6, in the illustrated embodiment, clamp108 extends about perimeter 126 of container 102 when clamp 108 is inits closed or clamped position. Clamp 108 may be formed from asubstantially rigid material, or in some embodiments, clamp 108 may beformed from a semi-rigid material such that clamp 108 can conform toperimeter 126 and/or the contours of container 102, which can aid insealing container 102 when clamp 108 is closed or clamped onto container102. Alternatively, clamp also may be formed from any other suitablematerial.

Clamp 108 is held in the closed or clamped position by a suitablesecuring mechanism, such as a latch 136. Referring particularly to FIG.5, latch 136 comprises a first arm 138 defining a catch 140 and a secondarm 142 defining a detent 144. In the depicted embodiment, first arm 138and second arm 142 are portions of clamp 108, such that clamp 108defines latch 136, i.e., latch 136 is integral with clamp 108. In otherembodiments, latch 136 may be any suitable mechanism for holding orfastening clamp 108 in its closed or clamped position, e.g., latch 136may be formed separately from clamp 108 and attached, coupled, orotherwise secured to clamp 108 to hold or fasten clamp 108 in the closedor clamped position.

As depicted in FIG. 5, clamp 108 includes a hinge portion 146 oppositelatch 136. In the illustrated embodiment, second arm 142 of latch 136pivots or hinges about hinge portion 146 to fasten detent 144 in catch140 and thereby clamp or close clamp 108. Similarly, when detent 144 isunfastened from catch 140, second arm 142 pivots or hinges about hingeportion 146 to unclamp or open clamp 108. In other embodiments, firstarm 138 defining catch 140 may pivot or hinge about hinge portion 146.In still other embodiments, clamp 108 may have other configurations forclosing and opening to fasten and unfasten latch 136 or other securingmechanism for holding clamp 108 in place on container 102.

As further illustrated in FIGS. 5 and 6, clamp 108 includes a verticalportion 148 extending along the vertical direction V. Vertical portion148 is positioned adjacent one or more vertical walls 112 of thecontainer 102. Clamp 108 also includes a horizontal portion 150 thatextends perpendicular to vertical portion 150. As depicted in FIG. 6,vertical portion 148 and horizontal portion 150 are arranged such thatclamp 108 has a generally L-shaped cross-section. Of course, in otherembodiments, clamp 108 may have other configurations, e.g., clamp 108may include multiple vertical and horizontal portions 148, 150 or,additionally or alternatively, may include one or more portions that areat an angle with respected to the vertical direction V.

In the illustrated embodiment of clamp 108, for example, as shown inFIG. 4, horizontal portion 150 defines an opening or window 152. Asshown, horizontal portion 150 extends about clamp 108 adjacent perimeter126 of container 102, and more particularly, horizontal portion 150extends inward from vertical portion 148 such that horizontal portion isadjacent opening 128 and volume 110 of container 102. However,horizontal portion 150 does not extend fully across opening 128, i.e.,the clamp 108 extends only partially across opening 128 defined by thecontainer 102, and a portion of sheet 106 of sterilization material isvisible and/or accessible through window 152 defined by horizontalportion 150.

In other embodiments, horizontal portion 150 may extend fully acrossopening 128. That is, horizontal portion 150 may extend between avertical portion 148 at first side 116 of sterilization packaging system100, a vertical portion 148 at second side 118, a vertical portion 148at third side 120, and a vertical portion 148 at fourth side 122.Accordingly, horizontal portion 150 may substantially cover opening 128,e.g., to protect sheet 106 of sterilization material that extends acrossopening 128 from punctures, cuts, tears, or like. In such embodiments,horizontal portion 150 may define one or more apertures for permittingthe ingress of sterilization fluid and the egress of, e.g., water orother fluid (while sheet 106 of sterilization material prevent theingress of contaminants as discussed).

Referring particularly to FIG. 6, exemplary clamp 108 also includes aprotrusion 154 defined by vertical portion 148 of clamp 108. Protrusion154 generally extends inward toward container 102. As illustrated inFIG. 6, when clamp 108 is positioned on container 102, protrusion 154protrudes into groove 130 defined by container 102. As such, protrusion154 may help seal container 102 and/or may help keep clamp 108 in placewith respect to container 102.

As also illustrated in the exemplary embodiment of sterilizationpackaging system 100, clamp 108 defines a depression 156. Depression 156generally is configured such that a second sterilization packagingsystem 100 may be stacked on top of clamp 108 of a first sterilizationpackaging system 100, as shown in FIG. 7. In the depicted embodiment,depression 156 substantially is a curved transition between verticalportion 148 and horizontal portion 150 of clamp 108. Other shapes,configurations, or the like of depression 156 may be used as well.

It will be readily understood that sterilization packaging system 100requires fewer packaging components than prior art packaging systemsusing rigid containers. Accordingly, the number of steps required toassemble sterilization packaging system 100, as well the costs of andthe material required for sterilization packaging system 100, is reducedcompared to known systems. Additionally, sealing assembly 104,comprising sheet 106 of sterilization material and clamp 108, provides aconsistent barrier against the ingress of contaminants while avoidingpost-sterilization breaches of the packaging system. Thus, sterilizationpackaging system 100 can increase confidence in the continued sterilityof items packaged therein after the package has been sterilized andstored. Of course, sterilization packaging system 100 also may haveother benefits and advantages.

Referring now to FIG. 8, a perspective view is provided of asterilization packaging system according to another exemplary embodimentof the present subject matter. In the depicted embodiment, sterilizationpackaging system 200 includes a frame 202, a sterilization wrap 204, anda top or lid 206. Generally, sterilization wrap 204 lines frame 202 todefine a volume 208 for containing items to be sterilized. Lid 206 ispositioned on a top portion 210 of frame 202, with sterilization wrap204 disposed therebetween, to seal volume 208 from the ingress ofcontaminants such as, e.g., bacteria and other infection causingmaterials or their vehicles. Once sealed, the sealed sterilizationpackage can then be transferred to sterilizing equipment and exposed tosterilization conditions as generally known in the art and as describedelsewhere herein. A sterility gauge 212 also may be included to indicatewhether the sterilized package has been breached.

Referring now to FIGS. 9 through 13, sterilization packaging system 200will be described in greater detail. In the depicted embodiment, frame202 defines a vertical direction V, a longitudinal direction L, and atransverse direction T, which are orthogonal to each other. Frame 202includes a plurality of vertical members 214 extending along thevertical direction V and a plurality of horizontal members 216 extendingperpendicular to the vertical direction V and vertical members 214. Eachvertical member 214 and horizontal member 216 has an inner side 218 andan outer side 220. That is, inner side 218 is opposite outer side 220such that each inner side 218 is oriented toward another inner side 218and is positioned adjacent sterilization wrap 204 lining frame 202 todefine volume 208. Together, vertical members 214 and horizontal members216 define a plurality of windows 222, and sterilization wrap 204 isvisible and/or accessible through windows 222. As shown in FIG. 9, frame202 also includes a horizontal bottom panel 224 extending perpendicularto the vertical direction V and vertical members 214 and betweenhorizontal members 216 at a bottom portion 226 of frame 202. Bottomportion 226 is generally vertically opposite top portion 210 of frame202.

In some embodiments, frame 202 is constructed from a rigid material. Inalternative embodiments, frame 202 is constructed from semi-rigid orother materials. In any event, frame 202—having vertical members 214,horizontal members 216, and bottom panel 224—provides structure toand/or strengthens sterilization wrap 204 to help prevent breaches ofsterilization wrap 204 due to, e.g., cuts, tears, or the like.

In the depicted exemplary embodiment, frame 202 is generally rectangularin shape, having four vertical sides defined by vertical and horizontalmembers 214, 216 and a horizontal bottom panel 224. In such embodiments,frame 202 may define a first side 228 of sterilization packaging system200 that is opposite a second side 230, e.g., first side 228 is spacedapart from second side 230 along transverse direction T, and a thirdside 232 opposite a fourth side 234, e.g., third side 232 is spacedapart from fourth side 234 along longitudinal direction L. Moreover, asshown in FIG. 9, frame 202 may include one or more handles 236, e.g.,for ease in transporting sterilization packaging system 200. Forexample, one handle 236 may be attached or pivotally coupled to ahorizontal member 216 at first side 228 of system 200 and another handle236 may be attached or pivotally coupled to a horizontal member 216 atsecond side 230, i.e., handles 236 may be attached or coupled onopposite sides of frame 202. Of course, frame 202 may have other shapesor configurations as well, e.g., frame 202 may be generally round inshape, include members at an angle to the vertical direction V, includeany number of handles 236, or may omit handles 236.

As illustrated most clearly in FIGS. 9 and 10, sterilization wrap 204may be shaped to closely match the shape enclosed by frame 202 andthereby line frame 202 to define volume 208. In other embodiments,sterilization wrap 204 may be positioned within frame 202 to generallymatch the shape enclosed by frame 202. In either case, a first portion238 of sterilization wrap 204 is positioned adjacent inner side 218 ofvertical and horizontal members 214, 216 to define volume 208 and anopening 240 to access volume 208. As shown in FIG. 11, sterilizationwrap 204 may be folded over to define a second portion 242 ofsterilization wrap 204. Second portion 242 is thereby positioned acrossopening 240 to cover opening 240. Further, when sterilization wrap 204is folded to define second portion 242, a fold 244 is defined betweensecond portion 242 and first portion 238 of sterilization wrap 204.Moreover, in some embodiments, sterilization wrap 204 may include a tab245 to assist in positioning sterilization wrap 204, e.g., for use as agrip when folding over sterilization wrap 204 to position second portion242 across opening 240.

Like sheet 106 of sterilization material described above, sterilizationwrap 204 can be made from a number of materials and, generally, may be amaterial from one of the two main classes, reusables and disposables,previously described. It has been found that polyolefin-based fibers andtheir resultant nonwovens are particularly well-suited for theproduction of sterilization wrap 204. Polypropylene spunbonded nonwovenssuch as are produced by Halyard Health, Inc. of Alpharetta, Ga., can beused to impart strength characteristics to sterilization wrap 204. Insome embodiments, sterilization wrap 204 may be made from laminates suchas a laminate of spunbonded and meltblown or spunbonded, meltblown,spunbonded to impart both strength and barrier properties tosterilization wrap 204.

A spunbonded-meltblown-spunbonded material is made from three separatelayers that are laminated to one another. The method of making theselayers is known and described in U.S. Pat. No. 4,041,203 to Brock, etal., which is incorporated herein in its entirety by reference. Thematerial of Brock, et al. is a three layer laminate ofspunbonded-meltblown-spunbonded layers that is also commonly referred toby the acronym “SMS.” The two outer layers of SMS are a spunbondedmaterial made from extruded polyolefin fibers, or filaments, laid downin a random pattern and then bonded to one another. The inner layer is ameltblown layer also made from extruded polyolefin fibers generally of asmaller diameter than the fibers in the spunbonded layers. As a result,the meltblown layer provides increased barrier properties due to itsfine fiber structure, which permits the sterilizing agent to passthrough the fabric while preventing passage of bacteria and othercontaminants. Conversely, the two outer spunbonded layers provide agreater portion of the strength factor in the overall laminate. Thelaminate may be prepared using an intermittent bond pattern that ispreferably employed with the pattern being substantially regularlyrepeating over the surface of the laminate. The pattern is selected suchthat the bonds may occupy about 5% to about 50% of the surface area ofthe laminate. Desirably, the bonds may occupy about 10% to about 30% ofthe surface area of the laminate. In an exemplary embodiment,sterilization wrap 204 is made from a SMS material, but sterilizationwrap 204 also may be made from other suitable materials.

As illustrated, sterilization packaging system 200 includes lid 206 forsealing volume 208 against an ingress of contaminants. Referringparticularly in FIG. 12, lid 206 is positioned at top portion 210 offrame 202 in contact with second portion 242 of sterilization wrap 204to seal volume 208. More specifically, lid 206 generally has a shapecomplementary to a shape defined by top portion 210 of frame 202 suchthat when lid 206 is positioned at top portion 210, lid 206 seals volume208 by preventing access to opening 240. In exemplary embodiments of thepresent subject matter, sterilization wrap 204 is disposable, i.e.,sterilization wrap 204 may be disposed of after it is used withinsterilization packaging system 200, while frame 202 and lid 206 may bereused. In other embodiments, as described above, sterilization wrap 204also may be reusable.

Continuing with FIG. 12, lid 206 comprises a lip 246 defined along aperimeter 248 of lid 206. Lid 206 further includes a flange comprising ahorizontal flange portion 250 adjacent lip 246 and a vertical flangeportion 252 adjacent horizontal flange portion 250. Horizontal andvertical flange portions 250, 252 define a recess 254. An inflatablegasket 256 is positioned in recess 254. As also illustrated, horizontalmember 216 of frame 202 defines a corresponding lip 258 and a flangecomprising horizontal flange portion 260 and vertical flange portion262. In the depicted embodiment, horizontal flange portion 250 of thelid flange rests on vertical flange portion 262 of the frame flange, andvertical flange portion 252 of the lid flange rests on horizontal flangeportion 260 of the frame flange. Thus, gasket 256 inflates within recess254 between flange portions 250, 252 of lid 206 and flange portions 260,262 of frame 202. Once inflated, gasket 256 compresses sterilizationwrap 204 between lid 206 and frame 202 to help seal volume 208 fromcontaminants. It will be readily understood that, in other embodiments,a suitable noninflatable gasket 256 may be used to help seal volume 208from contaminants and/or other configurations of lid lip 246 and flange250, 252 and frame lip 258 and flange 260, 262 may be used.

As further shown in the illustrated embodiment, lip 246 and horizontalflange portion 250 of lid 206 defines a depression 264 along perimeter248 of lid 206. Depression 264 generally is configured such that asecond sterilization packaging system 200 may be stacked on top of lid206 of a first sterilization packaging system 200, as shown in FIG. 13.In the depicted embodiment, depression 264 substantially is a lineartransition between lip 246 and horizontal flange portion 250. Lid 206also includes a plurality of ribs 266. In the illustrated exemplaryembodiment, ribs 266 extend horizontally between third side 232 andfourth side 234 of sterilization packaging system 200, i.e., generallybetween a portion of depression 264 defined along third side 232 and aportion of depression 264 defined along fourth side 234. Ribs 266 mayprovide rigidity to lid 206 and/or may support a sterilization packagingsystem 200 stacked on top of lid 206. Of course, in alternativeembodiments, depression 264 and ribs 266 may have other shapes,configurations, or the like.

Moreover, lid 206 may include one or more gripping portions 268, e.g.,for ease in positioning lid 206 to seal volume 208. For example, onegripping portion 268 may be attached to or defined by lid 206 at firstside 228 of system 200 and another gripping portion 268 may be attachedto or defined by lid 206 at second side 230, i.e., gripping portions 268may be attached to or defined on opposite sides of lid 206. Of course,lid 206 may include any number of gripping portions 268, which may beattached to or defined at any appropriate location of lid 206, or insome embodiments, gripping portions 268 may be omitted.

Sterilization packaging system 200 further includes a sterility gauge212 for signaling whether volume 208 is sealed against contaminants orhas been breached. As such, in an exemplary embodiment, sterility gauge212 comprises a binary visual signal, i.e., a signal having two outputs.For example, sterility gauge 212 may provide, as one of the two outputsof the binary signal, a green indicia in a viewport 270 of gauge 212 ifsterilization packaging system 200 remains sterile, i.e., if the sealremains intact and volume 208 has not be breached post-sterilization.Sterility gauge 212 may provide, as the other of the two outputs of thebinary signal, a red indicia in viewport 270 if system 200 is no longersterile, i.e., if volume 208 has been breached since the sealed packagewas sterilized such that the package should not be used. Sterility gauge212 also may be configured to provide the red indicia before the sealedpackage is sterilized and to provide the green indicia upon exposure tosterilization conditions; a subsequent breach of the package causes thesignal to revert to the red indicia. As shown in, e.g., FIGS. 11 and 12,sterility gauge 212 may be positioned on lid 206; for example, sterilitygauge 212 may be positioned on lid 206 adjacent first side 228 or secondside 230 of sterilization packaging system 200. Other configurations andoutputs of sterility gauge 212 may be used as well.

It will be readily understood that sterilization packaging system 200helps prevent cuts, tears, and the like that are common breaches inknown sterilization wrap packages. Accordingly, sterilization packagingsystem 200 utilizes the advantages of sterilization wraps, e.g.,providing a consistent barrier against the ingress of contaminants,while substantially avoiding disadvantages such as, e.g., tears, cuts,or other breaches, particularly in areas such as corners and edges thatare prone to such breaches. Moreover, features such as, e.g., sterilitygauge 212 can increase confidence that a sterilized package has not beenbreached. Sterilization packaging system 200 also may have otherbenefits and advantages.

Although described separately, the disclosure with respect tosterilization packaging system 100 also may be applicable tosterilization packaging system 200 and vice versa. That is, somefeatures described with respect to one system may also be used with theother system, e.g., in place of or in addition to features of the othersystem. As one example, sterility gauge 212 also may be included withsterilization packaging system 100 for indicating whether a packagesealed according to system 100 has been breached, i.e., for indicatingwhether the seal of system 100 remains intact.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the invention, including making and using any devices orsystems and performing any incorporated methods. The patentable scope ofthe invention is defined by the claims and may include other examplesthat occur to those skilled in the art. Such other examples are intendedto be within the scope of the claims if they include structural elementsthat do not differ from the literal language of the claims or if theyinclude equivalent structural elements with insubstantial differencesfrom the literal language of the claims.

What is claimed is:
 1. A sterilization packaging system, comprising: acontainer defining a vertical direction and a volume for containingitems to be sterilized, the container having a perimeter defining anopening through which the items to be sterilized are placed in thecontainer; and a sealing assembly, the sealing assembly including asheet of sterilization material, and a clamp for sealing the sheet ofsterilization material against the container, the clamp having an openposition and a clamped position, the clamp extending about the perimeterof the container when the clamp is in the clamped position, the clampcomprising a horizontal portion that defines a window, the horizontalportion extending inward with respect to the perimeter of the containersuch that the horizontal portion is positioned over the opening, whereinthe vertical portion projects vertically above the horizontal portion,wherein the horizontal portion is planar, and wherein the clamp curvesfrom the vertical portion vertically above the horizontal portion to thehorizontal portion to define a curved transition from the verticalportion to the horizontal portion.
 2. The sterilization packaging systemof claim 1, wherein the clamp further comprises a vertical portionextending along the vertical direction, and wherein the vertical portionintersects with the horizontal portion such that the clamp has anL-shaped cross-section.
 3. The sterilization packaging system of claim2, wherein the vertical portion of the clamp is positioned adjacent oneor more vertical walls of the container.
 4. The sterilization packagingsystem of claim 1, wherein the curved transition defines a depression,the depression configured such that a second sterilization packagingsystem may be stacked on top of the clamp and received in thedepression.
 5. The sterilization packaging system of claim 1, whereinthe sheet of sterilization material extends between the clamp and thecontainer such that the clamp contacts the sheet of sterilizationmaterial rather than the container.
 6. The sterilization packagingsystem of claim 1, wherein the clamp is held in the clamped position bya latch, and wherein the latch is integrally formed with the clamp. 7.The sterilization packaging system of claim 6, wherein the latchcomprises a first arm defining a catch and a second arm defining adetent.
 8. The sterilization packaging system of claim 7, wherein theclamp comprises a hinge portion opposite the latch.
 9. The sterilizationpackaging system of claim 8, wherein one of the first arm or the secondarm hinges about the hinge portion to place the clamp in the openposition or the clamped position.
 10. The sterilization packaging systemof claim 1, wherein the sheet of sterilization material is a breathablefilm.
 11. The sterilization packaging system of claim 10, wherein thebreathable film is transparent.
 12. The sterilization packaging systemof claim 1, wherein the clamp comprises a protrusion defined by avertical portion of the clamp and the container defines a groove,wherein the protrusion of the clamp protrudes into the groove when theclamp is positioned on the container, and wherein the sheet ofsterilization material extends between the clamp and the container suchthat the protrusion of the clamp contacts the sheet of sterilizationmaterial rather than the groove of the container.
 13. A sealing assemblyfor a sterilization packaging system, the sealing assembly comprising: asheet of sterilization material; and a clamp, the clamp having an openposition and a clamped position, the clamp further having an L-shapedcross-section formed by a vertical portion including a planar surfaceand a horizontal portion including a planar surface, wherein the clampis configured to extend about a perimeter of a container for containingitems to be sterilized, wherein the clamp is held in the clampedposition by a latch, and wherein the latch comprises a catch defined bya first arm of the clamp and a detent defined by a second arm of theclamp such that the latch is integral with the clamp, the detentconfigured to fasten in the catch to hold the clamp in the clampedposition.
 14. The sealing assembly of claim 13, wherein the clampcomprises a hinge portion opposite the latch, and wherein one of thefirst arm or the second arm hinge about the hinge portion to place theclamp in the open position or the clamped position.
 15. The sealingassembly of claim 13, wherein the sheet of sterilization material isconfigured to pass sterilant into the container and to retardtransmission of contaminants into the container.
 16. The sealingassembly of claim 13, wherein the vertical portion extends along avertical direction, the vertical portion positionable adjacent one ormore vertical walls of the container and the horizontal portion extendsperpendicular to the vertical portion, and wherein the horizontalportion defines a window.
 17. The sealing assembly of claim 13, whereinthe sealing assembly is disposable.
 18. A sealing assembly for asterilization packaging system, the sealing assembly comprising: a sheetof sterilization material; and a clamp having an open position and aclamped position, the clamp including a vertical portion extending alonga vertical direction, and a planar horizontal portion extendingperpendicular to the vertical portion, the horizontal portion defining awindow, wherein the clamp held in the clamped position by a latch,wherein the latch is integrally formed with the clamp and comprises afirst arm defining a catch and a second arm defining a detent, andwherein the sheet of sterilization material is visible through thewindow defined by the clamp when the clamp is in the clamped position.19. The sealing assembly of claim 18, wherein the sterilizationpackaging system comprises a container having a perimeter defining anopening through which the items to be sterilized are placed in thecontainer, and wherein the horizontal portion of the clamp extendsinward with respect to the perimeter of the container such that thehorizontal portion is positioned over the opening.
 20. The sealingassembly of claim 18, wherein the clamp comprises a hinge portionopposite the latch.